What's Happening?
Bayer has announced that the FDA has approved Lynkuet (elinzanetant), a dual neurokinin receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause. Lynkuet is the first and only medication of its kind, targeting neurokinin 1
and neurokinin 3 receptors to modulate neuronal activity associated with hot flashes. The approval is based on data from the Phase III OASIS clinical trials, which demonstrated significant reductions in the frequency and severity of hot flashes. Lynkuet is taken as a once-daily capsule and is expected to be available in the U.S. by November 2025.
Why It's Important?
The approval of Lynkuet represents a major advancement in the treatment of menopausal symptoms, providing a non-hormonal option for women who experience moderate to severe hot flashes. This is particularly beneficial for women who cannot use hormone therapy due to health risks or personal preference. The introduction of Lynkuet expands the range of available treatments, offering a new mechanism of action that could improve the quality of life for many women. As a leader in women's healthcare, Bayer's development of Lynkuet underscores the importance of innovation in addressing unmet medical needs in menopause management.
What's Next?
With Lynkuet's approval, Bayer plans to launch the drug in the U.S. market, supported by the Lynkuet Access Savings & Support program to ensure affordability and accessibility. The company is also pursuing regulatory approval in other countries, including the European Union. As Lynkuet becomes available, healthcare providers will likely evaluate its effectiveness and safety in real-world settings, potentially influencing treatment guidelines for menopausal symptoms. Bayer's commitment to women's health and the expansion of non-hormonal treatment options may drive further research and development in this area.
